150 mg, 300 mg hard capsules
rifampicin
What Rimactane is and what it is used for
Rimactane is an antibiotic that counteracts mainly tubercle bacteria.
Rimactane is used in combination with other medicines for tuberculosis.
Rifampicin contained in Rimactane may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Rimactane
Do not take Rimactane:
- if you are allergic to rifampicin or rifampicin-like medicines (rifamycins) or any of the other ingredients of this medicine (listed in section 6)
- if you have had any acute liver disease
- if you have had any hepatitis due to any medication you used
- if you have jaundice
- if you have the rare metabolic disease porphyria
- if you have severe kidney failure
- if you are taking the antifungal medicine voriconazole
- if you are using the malaria medicine artemether-lumefantrine
- if you are taking any antiviral medicines from the group of protease inhibitors (fosamprenavir, saquinavir, indinavir, ritonavir, nelfinavir, lopinavir, atazanavir, tipranavir, and darunavir) if you are taking medicines for hepatitis C infection (eg daclatasvir, simeprevir, telaprevir, sofas)
- if you are taking the heart medicine nifedipine
Warnings and cautions
Talk to your doctor or pharmacist before taking Rimactane:
- if you have impaired liver function or chronic liver disease
- if you have an increased risk of bleeding (eg if you are taking blood-thinning medicines or have a bleeding disorder)
Rimactane has intense red-brown color that especially at the beginning of the treatment stains teeth (can be permanent), urine, tears, and expelled mucus. Soft contact lenses can also be discolored in this way.
As the effect of birth control pills may be weakened by treatment with Rimactane, other contraceptive methods should be used during treatment. Complementary non-hormonal contraceptive methods are recommended.
Other medicines and Rimactane
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Rimactane should not be given at the same time as certain medicines, see section Do not take Rimactane.
Rimactane may affect the effectiveness of certain medicines against:
- Viral infections (eg nevirapine, raltegravir, maraviroc, abacavir, efavirenz, zidovudine and etravirine)
- Fungi ( ketoconazole , itraconazole, fluconazole and terbinafine)
- Bacterial infections (chloramphenicol, clarithromycin, ethionamide, doxycycline, metronidazole, sulfate methoxazole, trimethoprim, cefazolin, and telithromycin)
- Pain (morphine, paracetamol, etoricoxib, methadone, and codeine )
- Epilepsy ( phenytoin , carbamazepine, lamotrigine, phenobarbital and valproic acid )
- Heart problems, such as high blood pressure (verapamil, digoxin, amlodipine, disopyramide, propafenone, propranolol, metoprolol, carvedilol, diltiazem, and losartan )
- Blood clots, ie blood thinners ( warfarin )
- Malaria (chloroquine, atovaquone, mefloquine, quinine and artemeter lumefantrine)
- Rejection of organs after transplantation (cyclosporine, tacrolimus, everolimus, and sirolimus)
- Sleep problems and anxiety ( diazepam, zolpidem zaleplon, and buspirone)
- Depression (amitriptyline)
- Psychosis ( haloperidol, chlorpromazine, clozapine, and aripiprazole)
- High blood fats (fluvastatin and simvastatin )
- Gastric ulcer, heartburn, and acid reflux (ranitidine)
- Diabetes (glibenclamide)
- Inflammatory reaction in the body so-called corticosteroids (eg prednisolone )
- Cancer (imatinib, gefitinib, dasatinib, lapatinib, nilotinib, temsirolimus, pazopanib, irinotecan, erlotinib, sunitinib, sorafenib, and tamoxifen)
- Hypothyroidism (levothyroxine)
- Hepatitis C (eg daclatasvir, simeprevir, telaprevir, sofosbuvir)
Also, consult a doctor if you are using birth control pills as the effect of these may be weakened. Other methods of contraception are recommended during treatment.
Agents for heartburn and acid reflux (antacids) reduce the effect of Rimactane and therefore Rimactane should be taken within 1 hour of these.
Rimactane with food and drink
Dose one should be taken on an empty stomach, preferably ½ – 1 hour before breakfast.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is a risk that the fetus is affected.
Rimactane passes into breast milk.
Driving and using machines
The effect of Rimactane on the ability to drive and use machines is small or moderate.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rimactan contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Rimactane
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults is 450-600 mg or 10 mg/kg body weight once a day.
Rimactane capsules should be swallowed whole.
Use for children
Children are dosed by weight (10-20 mg/kg once daily), but not more than 600 mg per day for tuberculosis. In the first instance, another formulation is recommended for children. For children under 6 years of age, a form of medicine other than capsules is recommended, as there is a risk that the capsules may get stuck in the throat.
Children under 3 months of age should not be given rifampicin. Talk to your doctor.
If you take more Rimactane than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Rimactane
Do not take a double dose to make up for a forgotten dose.
If you stop taking Rimactane
Do not stop treatment without talking to your doctor first. If treatment is stopped too soon, the infection can flare up again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are symptoms from the stomach and intestines as well as skin reaction with redness.
Contact a doctor as soon as possible if you get any of the following rare serious side effects (which may affect up to 1 in 1,000 people):
- Allergic reactions with symptoms such as shortness of breath, itchy rash with redness along with fever and chills.
- Fever beginning to vomit or if skin and whites of the eyes turn yellow (jaundice). These symptoms may be signs of impaired liver function.
- Fever, chills and possibly headache, dizziness, and musculoskeletal pain. These symptoms may be signs of a cold-like syndrome and may be a warning of serious complications.
- Severe skin rash that may manifest itself as: –
- reddish spots on the torso, the spots are target-like or round, often with blisters in the middle
- scaly skin, sores in the mouth, throat, nose, genitals, and eyes
- widespread skin rashes with blisters
- The rash may be due to cold-like symptoms or fever, see above
- An infection with symptoms such as fever with severe general deterioration or fever with local symptoms of infection such as sore throat/pharynx/mouth or difficulty urinating. Rimactane can in rare cases affect the white blood cells so that the defense against infection deteriorates.
Other side effects are
Common (may affect up to 1 in 10 users:
- Elevated liver values.
- Fatigue, drowsiness, headache, dizziness, dizziness.
- Eye redness, permanent discoloration of soft contact lenses.
- Stomach pain, nausea, loss of appetite, flatulence.
- Redness, itching with or without rash, hives.
- Red discoloration of body fluids and secretions, e.g. urine, vomiting, tear fluid, feces, saliva, and sweat.
Rare (may affect up to 1 in 1,000 people):
- Disorders in the formation of red blood cells can cause heavily pigmented and colored skin ( porphyria ).
- Difficulty coordinating muscle movements.
- Coagulation disorder with blood clots.
- Visual disturbances, conjunctivitis.
- Diarrhea and vomiting, in some cases gastritis and inflammation of the colon, and pancreatitis.
- An increase in urea nitrogen and the level of uric acid in the blood, kidney failure, and kidney inflammation.
- Muscle weakness, muscle disease.
- Menstrual disorders (in the worst case no menstruation).
- Addison’s crisis (in patients with Addison’s disease ).
- Confusion, psychosis.
- Collapse.
Has been reported (occurs in an unknown number of users): Discoloration of teeth (may be permanent).
- Discoloration of teeth (may be permanent).
- Bleeding is because it takes longer for the blood to coagulate (caused by vitamin K deficiency).
How to store Rimactane
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. or EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is rifampicin. One capsule contains 150 mg and 300 mg rifampicin, respectively.
Other ingredients are:
Capsule content: lactose monohydrate, calcium stearate
Capsule shell 150 mg: gelatin, titanium dioxide (E171), red iron oxide (E172)
Capsule shell 300 mg: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)
Ink: Shellac, black iron oxide (E172), propylene glycol
What the medicine looks like and the contents of the pack
150 mg capsules are red and marked with 150 and NG. Capsule size: 6.35×18.0 mm.
300 mg capsules are red and marked with 300 and NG. Capsule size: 6.9×19.4 mm.
Pack sizes:
Blister pack: 100 capsules
Plastic jar: 100 capsules
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sandoz GmbH
Biochemistry. 10
A-6250 Kundl
Austria
Information is provided by Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark